Regulatory

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Announcement of the State Administration on approving the release of 16 medical device industry standards, including YY0285.5-2018 "Sterile catheters for single use in intravascular catheters - Part 5: Peripheral catheters with sleeve needles"

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第27号 Product Type Testing 2018-02-24 2019-03-01

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD

Announcement of the State Administration on approving the release of 9 medical device industry standards, including YY0645-2018 "Continuous Blood Purification Equipment"

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第8号 Product Type Testing 2018-01-19 2019-01-01

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device

Announcement of the State Administration on approving the release of 6 medical device industry standards, including YY/T0588-2017 Flow Cytometer

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第151号 Product Type Testing 2017-12-05 2018-12-01

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD

Announcement of the State Administration on Abolishing Two Medical Device Industry Standards, including YY/T0127.2-2009 Biological Evaluation of Oral Medical Devices Unit 2: Test Methods Acute Systemic Toxicity Test: Venous Pathway

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第130号 Product Type Testing 2017-11-01 2017-10-31

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device

Announcement of the State Administration on approving the release of 7 medical device industry standards, including YY/T0661-2017 "Semi crystalline Polylactide Polymer and Copolymer Resin for Surgical Implants"

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第118号 Product Type Testing 2017-09-25 2018-10-01

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device

Announcement of the State Administration on Approving the Issuance of Four Medical Device Industry Standards, including YY/T 1574-2017 Guidelines for Alginate gel Fixation or Microcapsulation of Tissue Engineering Medical Device Products

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第99号 Product Type Testing 2017-08-18 2018-09-01

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device

Announcement of the State Administration on approving the release of eight medical device industry standards and one amendment form, including "Sterile catheters for single use in intravascular catheters Part 1: General requirements"

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第84号 Product Type Testing 2017-07-17 2017-07-17

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device

Announcement of the State Administration on Abolishing 21 Medical Device Industry Standards, including YY0097-1992 Magnetic Therapy Health Cup

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第82号 Product Type Testing 2017-07-12 2017-07-07

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device

Announcement of the State Administration on approving the release of 28 medical device industry standards, including the "Disposable Centrifuge Plasma Seperator"

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第49号 Product Type Testing 2017-05-02 2018-04-01

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD

Interpretation of the Management Measures for Medical Device Standards

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170426 Product Type Testing 2017-04-26 2017-04-26

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD

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